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临床试验/NCT05125692
NCT05125692Unknown不适用

Vaginal Repair of Symptomatic Postcesarean Isthmocele: Evaluating A Simple Novel Technique

Mansoura University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
myometrial thickness in supracervical area

研究概览

简要总结

20 WOMEN WITH SYMPTOMATIC POSTCESAREAN ISTHMOCELE (NICHE) WILL BE RECRUITED EVALUATED AND SUBJECTED TO A VAGINAL REPAIR OF THE DEFECT, RESULTS WILL BE ANALYZED.

详细描述

METHODS:

  • Subjects: women in childbearing period with abnormal uterine bleeding or infertility attributed to post cesarean isthmocele (sample size to be calculated)
  • Preoperative evaluation: transvaginal ultrasound to exclude any other uterine or adnexal pathology, and to measure:
  1. Distance from the external cervical os to the lower end of the isthmocele (A)
  2. Distance from the external cervical os to the upper end of the isthmocele(B)
  3. Length of the isthmocele (B-A)
  4. Residual myometrial thickness (the least) of the isthmocele.
  • Routine preoperative workup.

  • The technique:

  • Postmenstrual

  • Spinal anesthesia

  • Sterilization of the perineum and vagina

  • Cervical dilation up to 8mm using Hegar's dilators

  • Marking the previously measured points A & B

  • Making 2 transverse incisions, one 5mm below A and the other 5 mm above B.

  • The rectangular area between the 2 incisions is excised while the Hegar's dilator number 8 in in situ.

  • Hemostasis is performed using diathermy.

  • The upper and lower edges of the incision are approximated using number 2/0 vicryl on cutting needle taking 3 to 4 interrupted sutures

  • The patients with uneventful postoperative course are discharged from hospital after 8 hours with doxycycline 100 mg bid for 5 days.

  • Sexual intercourse is avoided for 4 weeks postoperative

  • postoperative transvaginal ultrasound follow up; at 1 month postoperative.

  • Data will be statistically analyzed and results will be tabulated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •women diagnosed with symptomatic post cesarean isthmocele.
  • •should present with abnormal uterine bleeding .

排除标准

  • •presence of any other uterine pathology,
  • •presence of adnexal pathology,
  • •presence of malignancies,
  • •presence of pregnancy,
  • •presence of infection in the lower genital tract ,
  • •general cause of bleeding
  • •women not accepting the procedure,
  • •women not consented

研究组 & 干预措施

women with symptomatic post cesarean Istmocele

Other

vaginal surgical repair of post cesarean symptomatic isthmocele using conventional low cost surgical techniques

干预措施: vaginal surgical repair of isthmocele (Procedure)

结局指标

主要结局

myometrial thickness in supracervical area

时间窗: at 1 month postoperative

the myometrial thickness in the supracervical region is measured by transvaginal ultrasound postoperatively

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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